Kornimate/medical-research-clean huggingface dataset:
a real-world study to evaluate the safety and immunogenicity of a third-dose booster after two doses of an inactivated covid-19 vaccine

Conditions: COVID-19; Vaccine Reaction

Summary: this project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the covid-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. subjects received a third dose of the covid-19 vaccine will be enrolled in the study and followed up for 1 year at baseline (day 0) before vaccine injection, 28 days after injection, 90 days, 270 days after injection. on the 365th day, blood samples were collected for the detection of anti-sars-cov-2 antibodies and other related indicators to evaluate the immune protection effect.


Eligibility criteria:
inclusion criteria: * age \>18 years old, gender is not limited; * subjects who completed the second dose of covid-19 inactivated vaccine for more than 6 months and received the third dose of the same vaccine exclusion criteria: * allergic to the active ingredients of the sars-cov-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines; * those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory difficulties, urticaria, angioedema or abdominal pain); * receiving other research drugs within 3 months ;participating in other research vaccines or subjects in clinical trials of research drugs; * other conditions that the investigator judges are not suitable for this clinical trial;

Keywords: inactive vaccine
observational study of the durability of seroconversion chronic hbv patients who seroconverted in a previous gilead-sponsored study of adv.

Conditions: Hepatitis B

Summary: to investigate the durability of hbeag seroconversion in patients with chronic hepatitis b virus infection (hbv) who have seroconverted while participating in a previous gilead-sponsored study of adefovir dipivoxil.

the primary objective of this study is to investigate the durability of hbeag seroconversion in patients with chronic hepatitis b virus infection (hbv) who have seroconverted while participating in a previous gilead-sponsored study of adefovir dipivoxil. the secondary objective of this study is to investigate the durability of hbeag loss in patients with chronic hepatitis b virus infection (hbv) who have experienced durable hbeag loss while participating in a previous gilead-sponsored study of adefovir dipivoxil.

Eligibility criteria:
inclusion criteria: * must have met all inclusion criteria and none of the exclusion criteria and must have demonstrated hbeag seroconversion or durable hbeag loss as defined by the protocol in one of the following gilead-sponsored studies: gs-96-412, gs-98-437, gs-00-461 or ongoing or future gilead-sponsored studies identified by the sponsor to be eligible for this study. other patients who were enrolled in a now closed gilead-sponsored study of adv (gs-94-404, gs-96-412 initial phase or gs-96-413) and had previously demonstrated seroconversion or durable hbeag loss during their participation will be evaluated by the clinical research organization (cro) medical monitor for participation in this study on a case by case basis. * have documented negative serum hbeag with or without positive anti-hbe present at the two study visits prior to the final visit of the previous study. * a patient who has documented negative serum hbeag without positive anti-hbe must also have undetectable serum hbv dna (less than 1000 copies/ml using roche amplicor pcr assay) and normalized alt (less than uln) confirmed during these two studies. * all patients must be able to give written informed consent and comply with requirements of this study. exclusion criteria: * patients who seroconvert or experience durable hbeag loss during their participation in study gs-00-480 will not be eligible. * any serious or active medical or psychiatric illness that, in the opinion of the investigator would interfere with patient treatment, assessment or compliance with the protocol. * receiving any of the excluded medications listed in the protocol. * inability to comply with study requirements.

Keywords: chronic hepatitis b
a post-market clinical follow-up study in patients treated with vascular grafts

Conditions: Vascular Diseases

Summary: the flowgraft post-market clinical follow-up study is undertaken to show the safety and performance of flowweave bioseal, flownit bioseal, flowline bipore and flowline bipore heparin (combined named as vascular grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (imh), penetrating aortic ulcer (pau), contained rupture, stenosis in the aorta or peripheral arteries (lower limbs). this includes the use of flowweave bioseal or flownit bioseal for debranching of the head vessels in an alone standing procedure. furthermore, it includes the use of the flowline bipore and flowline bipore heparin grafts as arterious-venous (av) shunt.

in this study, patients who receive a vascular graft for the treatment of arterial diseases (aneurysm, pau, imh, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an av shunt will be observed. this includes patients in whom the vascular grafts are used for debranching or reconstruction of the head vessels. participating physicians will be asked to provide the observations, that were collected during routine care. written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection. the period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years at time of written informed consent * patient was selected for treatment with a commercially available vascular graft of jotec * patient satisfies at least one of the following categories: * acute (14 days) / subacute (15 - 90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb) * chronic (\>90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb) * aneurysm in the aorta or peripheral artery / arteries (lower limb) * imh in the aorta or peripheral artery / arteries (lower limb) * pau in the aorta or peripheral artery / arteries (lower limb) * contained rupture in the aorta or peripheral artery / arteries (lower limb) * stenosis in the aorta or peripheral artery / arteries (lower limb) * debranching of head vessels * av shunt * patient is willing and able to comply with all clinical study procedures and study visits. * patient has given written informed consent to participate in the study. exclusion criteria: * patient has any other medical, social, or psychological problem that in the opinion of the investigator preclude them from receiving this treatment, procedures, and evaluations pre- and post-procedure. * patient is scheduled for reconstruction of the tibial artery

Keywords: aortic aneurysm dissection stenosis pau imh
assessment of empagliflozin as adjuvant therapy in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. the purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. disease activity will be measured using mayo score for ulcerative colitis activity. calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.


Eligibility criteria:
inclusion criteria: * patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to mayo endoscopic scoring of ulcerative colitis. * adults (males and/or females) with age range from 18 to 65 years old. * patients on treatment with 5-aminosalisylic acid (5-asa) exclusion criteria: * patients with severe ulcerative colitis according to mayo endoscopic scoring of ulcerative colitis. * treatment with systemic or rectal steroids. * treatment with immunosuppressants. * previously failed treatment with a sulphasalazine. * known hypersensitivity to any of study drugs. * hepatic and renal dysfunction. * pregnancy and lactation. * history of colorectal carcinoma. * history of complete or partial colectomy. * patients with diabetes mellitus * patients with history of lactic acidosis * patients with disease states associated with hypoxemia including cardiorespiratory insufficiency * positive stool culture for enteric pathogens, positive stool ova and parasite exam.
cognitive and physical exercise to improve outcomes after surgery (cope-ios) study

Conditions: Cognitive Impairment; Disability Physical; Surgery

Summary: the cognitive and physical exercise to improve outcomes after surgery (cope-ios) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. to accomplish these goals, the investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. at baseline and after discharge, the investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional mri). in this early stage trial, the investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.


Eligibility criteria:
inclusion criteria: 1. ≥60 years old 2. undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days exclusion criteria: 1. blind, deaf, or inability to understand english as these conditions would preclude the ability to perform the proposed comprehensive program and prevent assessment with the study instruments 2. prisoners 3. severe frailty or physical impairment that prohibits participation in the program 4. cognitively unable to consent for surgery (i.e., dementia or cognitive impairment of a severity that precludes ability to self-consent and, thus, also participation in study interventions) 5. inability to obtain informed consent ≥2 weeks before scheduled surgery 6. surgical team unwilling to allow physical activity or other components of the intervention 7. inability or unwillingness to utilize a tablet device, laptop, or email 8. co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment
penicillin skin testing in patients with history of allergic reactions to betalactams

Conditions: Penicillin Allergy

Summary: this study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.

the results of skin test with immediate reading will be compared between alkali-treated penicillin g and dap reagents from diater

Eligibility criteria:
inclusion criteria: 1. patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins 2. 15-65 years of age exclusion criteria: 1. on antihistamine/ cannot discontinue antihistamine before the test 2. having asthma exacerbation 3. being pregnant 4. suffering from severe systemic disease/ in bad health

Keywords: penicillin beta-lactams allergy hypersensitivity
comprehensive nursing care protocol for women with pelvic organ prolapse and urinary incontinence: a global perspective

Conditions: Pelvic Organ Prolapse

Summary: pelvic organ prolapse is the descent of pelvic structures into the vagina due to ligament or muscular weakness. pelvic organ prolapse (pop) is subcategorized according to the compartment of descent. cystocele characterizes anterior wall herniation, rectocele refers to the posterior vaginal wall descent, and vaginal vault prolapse characterizes the descent of the uterus, cervix, or apex of the vagina. they can occur either singly or in combination

this study aimed to investigate the effectiveness of a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence in gynecological in patients departments, mansoura university hospital, mansoura university on their knowledge and practices as well as its impact on the women quality of life.

Eligibility criteria:
inclusion criteria: * all available nurses assigned for bed side care in the previous study settings and fulfilled the following inclusion criteria: * age 20≥ 60 years * willing to participate in the study * both sex exclusion criteria: * nurses did not assign for bed side care in the previous study settings and not fulfill the inclusion criteria

Keywords: women prolapse -care protocol
dynamic contrast enhanced (dce)-mri in fibromyalgia

Conditions: Fibromyalgia

Summary: the primary objective of the current pilot study is to analyze mri contrast-enhancement patterns in the hands of patients with fibromyalgia as compared to the findings in healthy controls. further, to compare enhancement patterns obtained in fibromyalgia patients with those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic arthritis. hypothesis: dynamic contrast-enhanced mri (dce-mri) of the hands in patients with fibromyalgia reveals pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g. superficial soft tissues and /or muscle with patterns distinct from those of inflammatory joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.

systematic, diagnostic studies applying dce-mri have never been performed in patients with fibromyalgia. however, characteristic contrast-enhancement patterns different from those seen in patients with rheumatoid arthritis and psoriatic arthritis have been observed in a small sample of fibromyalgia patients referred for dce-mri of the hands for differential diagnostic purposes at department of radiology, frederiksberg hospital. in these patients enhancement parameters indicative of vasodilatation and diffuse hyperperfusion involving subcutaneous tissues and muscles of the hands and fingers were found, whereas no synovial inflammation in joints or tendons could be demonstrated in the majority of these patients. whether these observations are part of a "normal" physiological perfusion in healthy individual or a potential novel marker of disease activity remains to be studied. if a pathological imaging pattern indicative of superficial soft tissue or muscle inflammation/hyper perfusion can be demonstrated it will have far-reaching implications for future research related to this patient population. not only may this line of research contribute to a better neurobiological understanding of fibromyalgia and the neurobiological link between inflammation and pain modulation, but also to the development of more objective examination methods, which will make diagnosing more reliable and less subjective. further, a better understanding of the neurobiology and phenomenological manifestations of fibromyalgia may have critical treatment implications

Eligibility criteria:
inclusion criteria: * age above 18 * fibromyalgia according to the 1990-acr research criteria * pain in the hands as a prominent clinical feature exclusion criteria: * other know medical condition capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy) * renal impairment * contraindications for mri

Keywords: fibromyalgia dce-mri neurogenic inflammation contrast-enhancement patterns
a study comparing siltuximab plus best supportive care to placebo plus best supportive care in anemic patients with international prognostic scoring system low- or intermediate-1-risk myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (rbc), transfusions to treat the anemia of myelodysplastic syndrome (mds).

the study treatments will be administered double-blind for 12 weeks, meaning that the patient and study personnel will not know the identity of the treatment. approximately 75 patients will be randomized (patients are assigned to a treatment by a chance) in a 2:1 ratio to receive siltuximab plus best supportive care (bsc) (group a) or placebo plus bsc (group b). bsc includes rbc transfusion, antimicrobials, white blood cell (wbc) growth factors, and platelet transfusions. patients who complete 12 weeks of treatment may qualify to receive siltuximab as open-label (identity of treatment will be known) treatment. treatment may continue until death, unacceptable toxicity, withdrawal of consent, or the clinical cutoff (defined as 24 weeks after the last patient is randomized), whichever occurs first. the study will end approximately 36 weeks after the last patient is randomized. patient safety will be monitored. siltuximab and matching placebo will be supplied as a sterile, lyophilized formulation for reconstitution and intravenous (iv) infusion. group a: siltuximab (15 mg/kg) administered as a 1-hour infusion every 4 weeks + bsc, or group b: placebo administered as a 1-hour infusion every 4 weeks + bsc.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of myelodysplastic syndrome (mds), according to world heath organization or the french-american-british cooperative group pathologic classification, with an international prognostic scoring system score 0, 0.5, or 1.0, indicating low- or int-1-risk disease. * documented rbc transfusion of at least 2 units of rbc for the treatment of the anemia of mds in the 8 weeks preceding the start of the screening period. * adequate iron stores, demonstrated by either the presence of stainable iron in the bone marrow or a serum ferritin of \> 100 ng/ml. * eastern cooperative oncology group (ecog) performance status score of 0 to 2. * symptomatic anemia (defined by a score \> 0 on the non-chemotherapy anemia symptom scale \[nca-ss\]). exclusion criteria: * had treatment with drugs or other agents targeting il-6 or its receptor within 4 weeks of randomization. * any condition that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments. * patients with chronic myelomonocytic leukemia (cmml). * causes other than mds contributing to anemia, such as vitamin b12 or folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic renal failure.

Keywords: myelodysplastic syndrome mds blood and lymphatic diseases siltuximab anemic
glutamate reducing interventions in schizophrenia

Conditions: Clinical High Risk for Psychosis

Summary: participants will be administered several doses of pomaglumetad (poma) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (mri) brain imaging to determine whether these doses of poma are affecting glutamate levels.

a double-blind, randomized, phase 1b, multiple dose trial of 14 days of treatment with poma (80 mg, 160 mg, 240 mg, 320 mg) in clinical high risk patients to determine which dose, if any, reduces glutamate and metabolism using mri techniques. the go no-go decision will be whether or not any dose tested in the r61 phase of the trial decreases left hippocampal ca1 region cerebral blood volume (cbv).

Eligibility criteria:
inclusion criteria: * capacity to provide informed consent * currently using a reliable form of birth control exclusion criteria: * metal implants in body or a history of metal working * lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents * lifetime diagnosis of renal failure/disease * acute neurological, neuroendocrine, or medical disorder including renal insufficiency (crcl\<40 ml/min/1.73m2) * lifetime diagnosis of hypertension or diabetes or seizure disorder * iq\<70 * acute risk for suicide and/or violence * pregnant lactating * current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics) * current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a mechanism of action like gabapentin), probenecid, selective serotonin reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors * more than one previous gadolinium scan